Z-0612-2019 Class II Terminated
FDA device recall Z-0612-2019 was initiated by Philips Medical Systems Gmbh, DMC on November 7, 2018 and is designated Class II. Reason for recall: kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose. The recall status is terminated (terminated September 2, 2020). Affected quantity: 146.
Recall Details
- Product Type
- Devices
- Report Date
- February 20, 2019
- Initiation Date
- November 7, 2018
- Termination Date
- September 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 146
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of: AZ, CA, GA, IL, MN, MO, MT, NJ, OH, TX, UT & VA; and to countries of: Australia, Austria, Bangladesh, Belgium, Chile C¿te D'Ivoire, Czech Republic. Egypt, Ethiopia, France, Germany, Ghana, Iran, Italy, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Philippines, Portugal Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.